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Human Milk Fortifier

Observational Case for Growth Delay

N/A
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 6 months
Awards & highlights

Study Summary

A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

Eligible Conditions
  • Growth Delay

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Growth
Secondary outcome measures
Head circumference growth
Linear growth

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational CaseExperimental Treatment1 Intervention
1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,243 Total Patients Enrolled
Prolacta BioscienceIndustry Sponsor
16 Previous Clinical Trials
1,591 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
Steven Abrams 2019. "Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04231630.
All > Heart Disease
~0 spots leftby May 2025
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